The following data is part of a premarket notification filed by Staubach Barror Water Systems, Inc. with the FDA for Aqua Pure Deionizer Exchange Service.
Device ID | K072158 |
510k Number | K072158 |
Device Name: | AQUA PURE DEIONIZER EXCHANGE SERVICE |
Classification | Subsystem, Water Purification |
Applicant | STAUBACH BARROR WATER SYSTEMS, INC. 495 ROTTERDAM IND. PARK Schenectady, NY 12306 |
Contact | Jarrod J Staubach |
Correspondent | Jarrod J Staubach STAUBACH BARROR WATER SYSTEMS, INC. 495 ROTTERDAM IND. PARK Schenectady, NY 12306 |
Product Code | FIP |
CFR Regulation Number | 876.5665 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-08-03 |
Decision Date | 2008-02-21 |
Summary: | summary |